Injectable Freeze Dry Operators are responsible for the operation of Freeze Dryers of B-41’s injectable drug product areas (Aseptic Processing North & South facilities). Work is performed in strict compliance with manufacturing standards (SOPs) and following all regulatory requirements (i.e., GMPs & OSHA). This job includes the following functions: aseptic gowning and personnel monitoring, processing of hazardous and non-hazardous drug products, computer skills, operating PLCs and SCADA systems, physical material handling (handling trays with product), assisting/preparing equipment for troubleshooting and completing GMP documentation. Colleagues are expected to share best practices with other colleagues on their shift, and across shifts.
In addition to freeze dry area, colleagues might be required to work in other areas, such as Injectable Filling, Inspection, or Packaging, as production demands require. Over-time and weekend work as production demands will be required.
Specific job functions include:
- Load and unload trays of product into and from freeze dryers and deliver to filling line
- Input data into complex automated control systems on several types of freeze dryers & product transfer cart
- Review freeze dry cycle charts or batch end reports and make GMP decisions on quality of run
- Wash, sanitize and operate transfer cabinets and loaders
- Understand general principles of lyophilization
- Demonstrating ownership and accountability to production schedule and protecting product quality
- Monitoring freeze dryers for efficient run time versus established standards
- Ensuring adequate inventory of parts and materials prior to initiating a production run
- Assisting maintenance in equipment troubleshooting
- Performing total productive maintenance/operator care tasks
Identifying and seeking to implement process and safety improvements
Executing in-process quality inspections
Recording GMP entries in batch record
Working in filling areas if required
Following all safety procedures (LOTO, Confined Space & Safe Work Permit)
Perform turnaround cycles (manual clean or CIP, SIP or VHP)
Developing corrective and preventive actions
Seeking value added tasks during unplanned line downtime
Completing and maintaining all required training on time
Other duties as assigned by the supervisor
Working under Aseptic conditions as schedule
Support execution of Capital Projects
- High school diploma / general education degree (GED) plus either an Associate’s degree or six months’ work experience (e.g. current or previous Pfizer colleague; Mfg, Pkg or Veterans/Military relevant experience).
- Math and reading skills required for SOP, GMP and Batch Record comprehension.
- Ability to contribute to department success in a team environment and perform tasks at a productive level under demanding conditions is mandatory.
- Must be self-motivated and willing to learn new and changing responsibilities. Requires a demonstrated ability to direct daily activities to meet production schedule.
- Experience: Completion of operator training program and required on the job experience as an Operator Assistant.
- Certificates, Licenses or Registrations: Fork-lift certification, as required.
- Language Skills: Effective written and oral communication
- Computer Skills: Microsoft Applications
- Physical Demands: lifting/lowering up to 55 pounds/ reaching/ standing/walking/stooping/crawling/working in high elevations (above 6 feet).
- Able to wear safety PPE (Hard hat, body harness, face shield).
- Able to work under full clean room gowning uniform.
Working Primarily 2nd shift (3:00 pm to 11:30 am) - Weekend, Holiday and overtime may be required.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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